FDA Broadens Ceritinib Indication

On May 26, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to ceritinib (Zykadia), a kinase inhibitor for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

In April 2014, ceritinib received accelerated approval for patients with ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib based on a blinded independent review committee--assessed overall response rate of 44% among 163 patients in a single-arm trial.

ASCEND-4 Trial

ASCEND-4 randomized 376 patients (1:1) to receive either ceritinib (n = 189) 750 mg orally once daily until disease progression or platinum-pemetrexed (Alimta) doublet chemotherapy (n = 187). Patients in the chemotherapy arm received pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC 5-6) on day 1 of every 21-day cycle for up to four cycles, followed by pemetrexed maintenance therapy.